THE VALUE OF ACCREDITATION

:CONSIDERATIONS FOR DECIDING ON SERVICE

PROVIDERS FOR CERTIFICATION /INSPECTION

VANI BHAMBRI ARORA

National Accreditation Board for Certification Bodies

QUALITY COUNCIL OF INDIA New Delhi

INTERNATIONAL SCENARIO

International trade is governed by WTO - free flow of trade - creation of global market with equal access to all countries.

Quality & safety have acquired center stage

Increasing use of standards for products, services, processes and systems - mandatory standards on grounds of health, safety, environment, national security, unfair trade practices.

Food sector facing stringent regulations and demand for private certifications

CONTD.

Need for checking compliance to prescribed standards –regulations and voluntary standards - conformity assessment – inspection/testing/certification.

Confidence in conformity assessment.

International acceptability for facilitating trade - Need for recognition of inspection/testing/ certification across borders.

Accomplished through accreditation

TBT AGREEMENT

“Members shall ensure, whenever possible, that results of conformity assessment procedures in other Members are accepted„adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation, with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence”

Article 6

A MODEL TO ASSURE COMPLIANCE

CONFORMITY ASSESSMENT

“Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled.”

Conformity assessment includes: sampling and testing; inspection; certification; and quality and environmental system assessment and registration, accreditation among others.

ISO 17000

CONFORMITY ASSESSMENTS

Need for Conformity Assessments

Globalization of Trade

Regulatory requirements

Assurance of Quality / competency

Cost effectiveness (Third party certification)

IS THERE A NEED TO ASSURE COMPETENCE

OF THIRD PARTIES WHO CERTIFY??

WHO CAN SET UP CERTIFICATION

BODY

Anyone

No legal bar on anyone setting up a certification body

Can be proprietorship, partnership, society, private or public limited – profit or non profit – governmental or private or non governmental organization

Generally all that is needed is people and documentation – unlike laboratory, no equipment or technology except IT tools

HOW DOES ONE DISTINGUISH AN

AUTHENTIC CERTIFICATION BODY

Governmental – some confidence

Private – what?

By name or brand

The only recognized means - accreditation

ACCREDITATION

Third-party attestation related to a conformity assessment body conveying

formal demonstration of its competence to carry out specific conformity assessment tasks – ISO 17000

Conformity assessment bodies – Certification bodies/ Inspection bodies/Labs QCI – responsible for national accreditation structure International Accreditation Forum (IAF) – Pacific Accreditation Cooperation

(PAC) - NABCB member from India International Laboratory Accreditation Cooperation (ILAC) – Asia Pacific

Laboratory Accreditation Cooperation (APLAC) - NABL member from India Basis of accreditation – generally international standards on conformity

assessment developed by ISO/ IAF or ILAC guidance documents

Primary purpose – facilitate trade by acceptance of certification/inspection/testing worldwide

GLOBAL VISION

A single worldwide program of conformity

assessment which reduces risk for business,

regulators and the consumer, by ensuring that

accredited services can be relied upon.

Government and Regulators relying on the IAF

and ILAC Arrangements (MLA / MRA) to further

develop or enhance trade agreements.

To support the freedom of world trade by

eliminating technical barriers, realizing the free-

trade goal of ‘Tested, Inspected or Certified Once

and Accepted Everywhere'

ACCREDITATION

FRAMEWORK

CONFORMITY ASSESSMENT

BODIES

International Standards

GOVERNMENT CONSUMERS PURCHASERS

CONFIDENCE TRUST ASSURANCE

PRODUCT & SERVICE PROVIDERS

Standards / regulatory

requirements / scheme criteria

ACCREDITATION

Peer

Evaluation

National Accreditation Bodies NABCB / NABL - India

International Accreditation Bodies IAF / ILAC

“The customer”

“The organization”

Certification / Inspection Bodies / Labs

CHAIN OF CONFORMITY

ASSESSMENT

Regional Accreditation Bodies PAC / APLAC / EA / IAAC etc.

Signatories to

MLA / MRA

Recognized Regions

by IAF / ILAC

BENEFITS OF ACCREDITATION

Recognition of certification/inspection/ testing by Indian conformity assessment bodies in other countries – NABCB signatory to IAF MLA – NABL signatory to ILAC MLA – certificates/test reports issued by accredited CABs accepted worldwide

Regulators accepting reports from IAF/ILAC members – examples Ecuador, South Africa

Increasing use in G-to-G MRAs – example India-Singapore MRA, draft India-EC agreement

Reduces risk for government, business and customers - international system - ensures through regular surveillance that Conformity assessment bodies are both independent and competent

Lower cost of accreditation – in turn lower cost of certification/inspection/testing for industry – enhances competitiveness

INTERNATIONAL EQUIVALENCE

Accreditation Bodies to comply with ISO 17011 – Peer Assessment – if successful, signatory to MRAs NABCB - Signed PAC MLA for QMS – Aug 2002; IAF MLA for QMS – Sept 2002; Signed PAC MLA for EMS – July 2007; IAF MLA for EMS – Oct 2007; Product – PAC MLA signed May 2013 – IAF MLA in Oct 2013; APLAC and ILAC MLA for IBs since Sept 2013; FSMS PAC MLA in June 2014; ISMS PE was conducted in Nov 2014 NABL – signatory to ILAC/APLAC MRAs for Testing and Calibration Labs since 2000; APLAC MRA for medical labs Dec 2008 • No equivalence yet in FSMS/HACCP certification • NABCB accreditation equivalent worldwide and certificates with NABCB logo acceptable internationally • Sum up – India has world class accreditation infrastructure

EMERGING REGIME

Regulatory regime – Regulatory bodies increasingly seeking accredited CABs – more prevalent in non-food sectors – EC’s agreements with Australia, USA, Japan etc; India-Singapore MRA, APEC MRAs - growing in food - growing in food - e.g. HACCP accreditation in Australia on Victorian Meat Authority’s request in 1997 – UK DEFRA to use accredited micro labs - MFPI’s MoU with QCI (HACCP/GHP/GMP etc) in 2005 – MoH’s request to QCI for accreditation of agencies for checking GMP/GHP compliance in 2006 -India’s Food Authority to rely on NABCB/NABL accreditations

Voluntary standards – market driven – ISO 9001/14001/ 22000/27001 etc, generally retail industry driven – Scheme owners - Globalgap, GFSI, SQF, GOTS, Organic – prescribe accreditation as requirement for CBs, IBs and Labs

EC Regulation – legislation on accreditation in July 2008 – wef 1 Jan 2010 – single national accreditation body – public, non profit, non competition, impact worldwide

EMERGING STRUCTURE

Government

(to enact legislation)

Regulatory Bodies – may be sector specific like Food, Drugs

(to enforce the law)

Accreditation Body

(technical competence of CABs)

Conformity Assessment Bodies (CABs)

(support regulation – voluntary certification/quality assurance)

Manufacturers and Service providers

Common man – recipient of goods and services

USING ACCREDITATION PNGRB and FSSAI relying on accredited agencies

MSME and MFPI – providing financial assistance to industry going for NABCB accredited CB for certifications

Railway Minster’s announcement in Railway Budget – catering services to be audited by NABCB accredited third party agencies

NABCB accreditation referenced in free trade agreements

Many govts – Orissa, Uttarakhand, BMC – prescribing NABCB accredited inspection bodies for construction

NABCB MoU with IT ITeS SSC in NASSCOM

Dialogue with NSDA – broad agreement to use accredited evaluation bodies

PRINCIPLES OF CERTIFICATION

Impartiality

Competence

Responsibility

Openness

Confidentiality

Responsiveness to complaints.

ISSUES IN CERTIFICATION

Worldwide concern about quality of ISO 9000 and other certifications

Integrity and ethics an issue in India

About 15 CBs penalized by NABCB - 10 suspensions, 6 cancellations, 2 applications rejected – 2 cancellations in last 3 months -almost all on malpractice

Typical issues – all auditors not going on site, TEs not going on site, audit days reduced, nexus with consultants

Franchisees – under less oversight – issuing unauthorized certificates not declared to their principals or AB

Less oversight of foreign ABs – many foreign ABs operating in India

ISSUES IN CERTIFICATION

Many private ABs not members of IAF/ILAC system

Many CBs in market accredited by such ABs

No way to ascertain credentials – no oversight

Insist on IAF/ILAC MLA signatory – at least member

Insist on AB logo

TO CONSIDER

Use accreditation

International system

Reduces risk in using third party assessment

Insist on certificates bearing AB logo

As user, free to exercise choice

ABOUT QCI

Established in 1997 by a Cabinet decision – in partnership with CII, FICCI, ASSOCHAM – independent, non profit, successful PPP

Autonomous body – regd as society - Chairman appointed by PM (Ratan Tata, Venu Srinivasan, Dr. R.A.Mashelkar) – Currently Mr. Adil Zainulbhai

Provide accreditation structure in the country

Spread quality movement in India – assigned National Quality Campaign funded by Govt

Provide right and unbiased information on quality & related standards

Represent India’s interest in international fora

Help establish brand equity of Indian products and services

STRUCTURE OF QCI

QUALITY COUNCIL OF INDIA

NATIONAL

ACCREDITATION

BOARD FOR

CERTIFICATION BODIES

(NABCB)

NATIONAL BOARD FOR

QUALITY PROMOTION

(NBQP)

NATIONAL

ACCREDITATION BOARD

FOR TESTING AND

CALIBRATION

LABORATORIES

(NABL)*

NATIONAL

ACCREDITATION

BOARD FOR

EDUCATION AND

TRAINING

(NABET)

NATIONAL ACCREDITATION

BOARD FOR HOSPITALS AND

HEALTHCARE PROVIDERS

(NABH)

*CURRENTLY INDEPENDENT BODY

NABCB STRUCTURE

Constituent Board of Quality Council of India

Established by Govt in partnership with CII, FICCI, ASSOCHAM

Board – apex - multistakeholder – Chairman – Mr. N. Kumar, Sanmar Group

3 member Accreditation Committee

Secretariat - CEO supported by 5 technical and two non technical staff – common services like Accounts, HR, services provided by QCI

Pool of external assessors – 40 nos supported by TEs

NABCB

Schemes in operation Quality Management Systems/ISO 9001

Environmental Management Systems/ISO 14001

Food Safety Management Systems/ISO 22000 and others

Product Certification as per ISO Guide 65/ISO 17065

Inspection Bodies as per ISO 17020

ISMS and ITSMS

Personnel Certification as per ISO 17024

ISO 13485

ISO 50001

STATISTICS

QMS-43 (5)

EMS-13(3)

OHSMS-7(4)

FSMS-15 (6)

ISMS-3(0)

EnMS- 1(5)

IB Scheme- 19 (15)

PC scheme-4(4)

QMS-MD: 0(0)

ITSMS- 1

SCHEMES PLANNED

GHG Validation/Verification Bodies as per ISO

14065

Primary packaging materials for medicinal

products – Particular requirements for the

application of ISO 9001:2008 certification as

per ISO 15378

Road Transport Safety Management System as

per ISO 39001

Aerospace Management Systems as per AS

9100

INFORMATION ON ACCREDITATION

Quality Council of India

2nd Floor, Institution of Engineers Building 2, Bahadur Shah Zafar Marg

New Delhi - 110002 INDIA

Telefax : +91-11-23379321/9260/0567/8057

Email : info@qcin.org, nabcb@qcin.org,

Website : www.qcin.org

THANK YOU

FOR YOUR ATTENTION!